With the end of the year around the corner, the transition period after Brexit is about to come to an end. From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the United Kingdom’s standalone medicines and medical devices regulator.
In order to ensure that all the involved parties can be ready for the new scenario, MHRA has published guidance on how Medical Devices (MDs) will be regulated from 2021 on.
Here we present a summary of the highlights that should be considered if planning to market (or have already marketed) a device in the UK.
- Placing devices in the UK
From 1 January 2021 a new marking will be available for devices in the UK, the UK Conformity Assessed (UKCA) mark. MHRA will designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA, and existing UK Notified Bodies will have their designations rolled over automatically. CE marking will continue to be used and recognized until 30 June 2023, but from that point on UKCA marking will be mandatory for all medical devices.
In addition to this new marking, all the manufacturers will have to be registered with the MHRA. This registration will apply from 1 January 2021, albeit a grace period has been provided by MHRA, ranging from 4 months to a year, depending on the classification of the device.
Also, manufacturers which are not established in the UK, will have to designate a UK Responsible Person. This requirement will be in line with the grace period for the registration with MHRA. The UK Responsible Person will act as the Authorised Representative in Europe for manufacturers not established in the European Union (EU), being responsible, amongst others, of keeping a copy of the Technical Document, providing MHRA with all the information and documentation necessary or forwarding the manufacturer any request by MHRA.
- Northern Ireland
A critical point regarding the new scenario is the particular situation that will take place with Northern Ireland, as there will be major differences between the rules for placing a MD on Northern Ireland and those applicable to Great Britain. The specific rules applicable to Northern Ireland are detailed in the Northern Ireland Protocol.
MDR and IVDR will apply in Northern Ireland from May 2021 and May 2022, respectively, as in the rest of Europe, and devices marketed in this region must be CE marked, either by an European Notified Body or by an UK Approved Body. However, CE marking by an UK Approved body will not be accepted in the rest of Europe.
It shall be clarified that the UKCA alone will not be accepted in Northern Ireland, CE marking will still be necessary for its placing on the market of Northern Ireland.
- Useful terminology
Due to the upcoming changes, particularly in the applicable legislations depending on the territory, it is important to keep the terminology updated so as not to misunderstand any relevant concepts. A summary of critical aspects of the regulation of MDs and their related terminology is included below:
|Topic||CE MARKING||UKCA||UK (NI)|
|Region affected||European Economic Area||Great Britain (England, Scotland and Wales)||Northern Ireland|
|Legislation ruling medical devices||Directives|
2017/745 and 2017/746
|UK MDR 2002 (transposition of the 3 directives)||Will work like Europe with some differences|
|Local representative for foreign manufacturers||European Authorized Representative (ECREP or EAR)||UK Responsible person|
|Organizations responsible for conformity assessment evaluation||Notified Body|
|UK Approved Body|
|Name of the documentation with the technical information||Technical File||Technical Documentation||Technical Documentation|
|Name of the requirements||Essential Requirements||General Safety and Performance Requirements||Technical Requirements|
|Standards||Harmonized standards are identified by prefix ‘EN’||As of 1 January 2021, UK designated standards will use prefix ‘BS’ to indicate that is has been adopted by the British Standards Institution (UK’s national standards body)|
Asphalion, an International Scientific and Regulatory Affairs Consultancy with extensive knowledge on medical devices (and with offices throughout Europe and UK), can ease your path through this transition, assessing you on each step of the way.
Contact us at email@example.com to obtain specialized advisory and support!